viernes, 24 de noviembre de 2017

(Some notes for
discussion at the “Game Changers” meeting, “for better and affordable medicines
for Europe” organized by European Public Health Alliance, under the auspices of
the Bulgarian Ministry of Health. November 21, 2017; Brussels).

1.Introductory
remarks.

In his beautiful
novel “Lord Jim”, Joseph Conrad describes the abuse of monopoly power by the Rajah
Allang, the king of a remote place called Patusan.

“Rajah Allang
–writes Conrad- pretended to be the only trader in his country, and the penalty
for the breach of the monopoly was death; but his idea of trading was indistinguishable
from the commonest forms of robbery”.

In my view, the
main anti competition strategy in the pharmaceutical sector is, precisely, to consolidate,
reinforce and expand the monopolies, the dominant position granted through patents, data exclusivity and supplementary protection certificates.

Unfotunately, there
are two dramatic consequences of abusing dominant position in this field. On
one hand, thousands of people here in Europe and all over the world suffer, and
die prematurely due to lack of access to the medicines they need.

On the other
hand, patients and health systems are losing a lot of resources that go to the
profits of pharma companies, putting the sustainability of public health care
services at risk.

Let’s see some
numbers. According to the European Federation of Pharmaceutical Industries and Associations (EFPIA) the pharmaceutical market value at ex factory
prices (in the EU-28 Member States) reached € 166 billion in 2015. We, the patients
and the health systems are already paying that money.

How much are the manufacturing
costs? We can estimate these costs from the European Pharmaceutical Sector
Inquiry, where they calculated that pharma companies spent 21% of total sales
in manufacturing. That means that pharma industries would have spent around €
35 billion. Then, why are we paying €166 billion? Because we pay a kind of "TAX" called "Patent”. An overprice that companies collect with the justification
that this money is needed to finance R&D. The companies can collect this "TAX" thanks to the monopoly granted by governments, and we, consumers, patients, health services, are paying R&D through this "TAX" (see Baker, Jayadev, Stiglitz 2017).

So, in addition
to the manufacturing costs, we are paying €131 billion. How much did pharma
companies spent in R&D? According to EFPIA they spent only €26.5 billion in
2015.

It is a lot of money,
but we if we are paying €131 billion in order to finance R&D through the
patent system, where goes the difference? The difference, more than €104
billion, goes to profits and other related expenditures. It is not going to
research.

A key point of
this model is that a significant part of these profits, around €38 billion, are
used in marketing strategies, advertising, sponsoring, lobbying, visits by
sales staff to doctors and pharmacists, etc., in order to maintain the
monopolies, justifying the astonishing increase in prices and delaying the
entry of generics. That's the reason why it is very dificult to change the
system.

The rest of the
money goes to mergers and acquisitions, stock buybacks, remuneration of top
executives, dividend payouts, lawyers and litigations, etc. Indeed, we could say
that it is a very unfair and inefficient system for patients and health systems,
but very profitable for some pharma companies.

How do companies
abuse their dominant position?

Article 102 of the Treaty on the Functioning of the
European Union explains that
abuse of dominant position may consist in:

a)-imposing
unfair prices.

b)-limiting markets to the prejudice
of consumers.
c)-applying dissimilar conditions to equivalent transactions.

etc.

All these kind of
abuses of monopoly power, that perhaps Conrad would have considered indistiguishable
from the commonest forms of robbery, are being applied systematically in the
pharmaceutical sector and should be prohibited by the EU authorities, according
to article 102. (At the end I will discuss these three types of abuse of
dominant position).

Is there a way out?

Yes. There are
different initiatives and interesting strategies, that respond to different
aspects of the problem (for example, improving transparency in order to
negotiate better prices, abolishing the supplementary protection certificate,
implementing compulsury licences, reducing data and market exclusivity, obtaining
returns from direct public financing on research, etc.). But, in my view, the
way out is Delinkage: delinking the financing of R&D from prices, and
abolishing the patents for medicines.

The alternative
to the current model is to finance directly researchers and research centres,
using the money that we are spending paying over-prices. There are
different ways of doing that, centralized and decentralized (National
Institutes, grants, subsidies, prizes, contracts, etc.), and there are a lot of
positive experiences (see University Allied for Essential Medicines, UAEM reports).

Research and
development with direct public funding should reach the approval stage for
commercialization. Afterwards, the pharmaceutical companies could manufacture
the medicines at an affordable price (like generics).

With the
resources that we are spending now we would be able to pay for the
manufacturing (€35 Bn), and to dedicate the same €26.5 billion to open and
collaborative research, with priorities related to health needs of the
population and not only to commercial interests.

The rest of the
money, more than €104 billion could be used to improve health conditions of the
population. This money could be spent, for example in public health programmes,
disease prevention, better nutrition, health promotion, and to reinforce public
health care services improving quality, safety and access. And we could still
save some money.

For the last 30 years
we have been thinking and discussing prices and affordability of medicines
within the framework designed by Pharma corporations. Now we have to change the
framework, and we have to think with other perspective based on human rights,
and considering drugs as public goods, rather than as financial products. We
need to delink prices of medicines from the financing of R&D in order to
guarantee access to medicines for all person who need them.

It is not an easy
goal, it will take time, but in my humble opinion it is the only way out.

2. Is competition
legislation being violated in the pharmaceutical sector?

2.1.

Imposing unfair prices.

In order to maximise their profits, companies may develop
different strategies: the first one is to use their dominant position to impose
the maximum price that patients and health systems can bear.

In my opinion,
Article 102, point a) is being infringed when some pharma companies impose unfair
prices to medicines.

How can we define a price as unfair?

In the Judgement
of the Court of 14 February 1978, case 27 / 76, The Court of Justice discussed
if a price could be considered unfair or excessive: this excess could be determined by making a comparison between the selling price
of the product in question and its cost of production…

The Judgement stated
that, in order to assess if a price has been imposed which is either unfair in
itself or when compared to competing products the Commission should require the
companies to produce particulars of all the constituent elements of its
production costs.

Once we know the difference between
production costs and prices, what proportion do we consider excessive? A
disproportion between costs and prices about 100%, or 1,000%, or 10,000%?

Andrew Hill and other researchers
have drawn attention to the difference between production costs and prices:

Sofosbuvir, with a cost of
production of €55 per treatment, is sold at a price of €13,000. The
difference between costs and prices is 20,000%.

Entecavir, with a cost of production
of €36 per person / per year of treatment, has a price of €6,000. The difference
between costs and prices amount to 16,000%.

Imatinib, with a cost of production of €180 per person / per year, is sold at a price of €30,000. The difference is
16,000%.

Insulin, with a cost
per vial of 1€, has a price per vial, €100. The difference is 10,000%.

The anual cost for a
combined treatment for HIV/AIDS with Tenoforvir, Embricitabine, and Efavirez,
is €80. The price is around €7,000. The difference amount 8,000%.

Are these prices disproportionate?

Let’s
be clear. Exorbitant prices are not aimed to finance R&D to discover new
medicines. Hepatitis C drugs prices, cancer drug prices, HIV drug prices are
not justified by the investment companies have done in R&D. Prices are fixed considering the maximum price that the market will bear.

In a
paper published in JAMA last september, Prasad and Mailankody, studied 10
cancer drugs, comparing sales and R&D costs. In 4 years since approval, the
total revenue from sales of these 10 drugs was $67.0 billion compared with
total R&D spending of $7.2 billion. Expenditure on R&D was only 10.74%
of sales. In other words, in less than 2 years they have covered R&D costs.
If governments were not able to impose fair prices, then it would be reasonable
to terminate the patent protection and date exclusivity when companies have
recovered R&D costs.

In the case of
Sofosbuvir, studied by US Senators Wyden and Grassley, R&D costs were
recovered in the first year of sales.

The Aspen case:

Altroconsumo (Italian Consumer Organization) launched the case in 2015 after consumers complained about the shortages of these medicines. Then, the European Consumer Organization (BEUC) urged the European Commission to investigate this "unethical" practices of drug pricing, an example of abuse of dominant position.In May 2017, the
European Commission opened a formal investigation into concerns that Aspen
Pharma had engaged in excessive pricing concerning five life-saving cancer
medicines. The Commission will investigate whether Aspen has abused a dominant
market position in breach of EU antitrust rules. It is the first investigation
of the Commission about excessive pricing practices.

The Commissioner in
charge of competition policy, said: “in this case we will be assessing whether
Aspen is breaking EU competition rules by charging excessive prices for a
number of medicines."

It would be an excelent
opportunity for the Commission to define what prices should be considered
Excessive Prices. This criteria should apply not only to a generic company who
has increased prices in excess, but also to originator companies when they set
unjustified prices from the begining.

For example, if a generics
company uses its dominant position to increse prices 1,000%, from 10 to 100 euros, this is
unfair; but also, when originator companies use their monopoly power to set
prices at 10,000% over costs (including R&D costs), from 100 to 10,000
euros, they are abusing the dominant position granted by patents. These
companies are imposing every day very significant and unjustified prices, and
the Commission should investigate this infringement of article 102.

Given the importance of
this issue to the European Union and its citizens, should not the Commission
(in colaboration with the National Competition Authorities) routinely
investigate the costs, prices and benefits of the 20 top selling drugs, and the
20 high priced drugs in the EU?

It is important to remind
that the problem of astonishing and unfair prices is not going to be solved alone.
In fact, prices of new medicines are escalating every day, putting the economic
viability of public health care services at risk.

2.2.

Limiting markets to the prejudice of
consumers, designing and
implementing a network of strategies aimed to delay generics entrance.

Art 102, point b) is being infringed
when companies abuse their dominant position “limiting production, markets or
technical development to the prejudice of consumers".

The results of the Pharmaceutical
sector inquiry carried out by the EU Commission in 2009, suggest that the
behaviour of originator companies contribute to the obstacles for generic entry.
Similarly, in 2014, the Chair of the OECD Competition Committee, when
Discussing on Competition and Generic Pharmaceuticals, concluded that many
examples were provided revealing questionable strategies developed by
originator companies. “These cases –he said- showed that originator firms have
quite some imagination when it comes to maximizing their profits”.

Pharma Companies
offer different prices to different countries, different regions, different
sick funds, or even different hospitals, through discrete negotiations,
reaching agreements on prices that sometimes must be keeped secret.

Art 102 of the Treaty on the Functioning of the European Union states that
abuse of dominant position may, in particular, consist in:

(c) applying dissimilar conditions to equivalent
transactions with other trading parties, thereby placing them at a competitive
disadvantage;

In the Court Judgement of 14 of February 1978, case 27 /76, was stated that
“the policy of differing prices, enabling
a company to apply dissimilar conditions to equivalent transactions with other
trading parties, was an abuse of a dominant position”.

We can observe that in the pharma
sector differing prices are very common. Companies negotiate confidential
agreements, setting differing prices in various European Countries. They
explain that in that way they can charge lower prices to lower income
countries: charity-like marketing. The reality is that this abuse of dominant
position allow them to charge higher prices in relation to real costs
everywhere. The maximum price that the market could bear in each country, far
above production costs.

For example, the WHO Global report
on Access to Hepatitis C treatment (October 2016) showed the differing prices
charged in different countries. The document shows that prices of sofosbuvir differ
more than 50% between EU countries. The report states that: to enable countries
to successfully negotiate more affordable prices, greater market transparency
is needed. And also indicates that: lessons
learnt from the HIV field show that generic competition is more effective in
driving down prices.Confidential
agreements imposed by some pharma companies are infringing art 102 of EU
Treaty.

Applying
the clasic principle “Divide and rule”, confidential agreements give the
industry all the power to continue ruling pharmaceutical market, maximizing
their benefits while patients and health services have to pay unfair, excessive
prices.